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A site-specifically conjugated HER2 ADC beat lapatinib-capecitabine on progression-free survival in China.
ACE-Breast-02, a Chinese phase 3 sponsored by Zhejiang Medicine and Ambrx and reported in 2024 (it is registered in China rather than on ClinicalTrials.gov; NCT04829604 is the separate US study ACE-Breast-03), showed that ARX788, a HER2 antibody-drug conjugate made with site-specific conjugation, beat lapatinib plus capecitabine on progression-free survival in HER2-positive advanced breast cancer after trastuzumab and a taxane in China. It randomised 441 patients and met its primary endpoint with a clear reduction in the risk of progression; ARX788 uses non-natural amino acid conjugation from Ambrx, now part of Johnson & Johnson, with an MMAF-like payload, and ocular and pulmonary toxicity were noted. OnCo links it to site-specific conjugation and linker chemistry, ARX788 and lapatinib; a marketing application is planned in China with FDA Fast Track status. It is a single phase 3 against an older comparator, so how ARX788 compares with trastuzumab deruxtecan is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Shares Ambrx, ARX788, Site-specific conjugation & linker chemistry, HER2-positive breast cancer.
Shares Lapatinib, HER2-positive breast cancer.
Shares ARX788, HER2-positive breast cancer.
Shares Lapatinib, HER2-positive breast cancer.
Shares Lapatinib, HER2-positive breast cancer.
Shares Lapatinib, HER2-positive breast cancer.